NCT04366115

Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: AVM Biotechnology Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a single intravenous (IV) infusion to patients with moderate or severe immediately life-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza (A or B). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose of AVM0703 in these ARDS patients.

Detailed description

The primary objective of the study is to evaluate the safety and tolerability of a single dose of AVM0703 in patients with moderate, severe or immediately life-threatening ARDS due to COVID-19 or Influenza (A or B) infection. The secondary objectives of the study are to 1) evaluate the pharmacokinetics (PK) and 2) evaluate potential clinical findings following a single dose of AVM0703. The exploratory objective of the study is to assess potential biomarkers indicative of natural killer T (NKT) cell activity and biomarkers predictive of response to AVM0703 in peripheral blood and bronchoalveolar lavage. The results of the Phase 1 study will guide the design of the Phase 2 study.

Conditions

• ARDS
• Covid19
• Influenza, Human

Interventions

Type	Name	Description
DRUG	AVM0703	Single IV infusion at 10 mg/mL in normal saline over 1 hour to patients.
DRUG	Placebo	Single IV infusion in normal saline over 1 hour to patients.

Timeline

• Start date: 2026-12-01
• Primary completion: 2031-12-01
• Completion: 2032-03-01
• First posted: 2020-04-28
• Last updated: 2025-10-02

Regulatory

• FDA-regulated drug study